Sr. Program Manager, Regulatory Affairs

Overview

Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.

 

The Senior Program Manager, Regulatory Affairs will lead complex, multi-year strategic initiatives for successful implementation of governmental regulations (including EU MDR) and other key business initiatives. The ideal candidate will lead assigned programs and provide program management structure to cross-functional workstreams working on critical deliverables. The Senior Program Manager will work with Regulatory management to provide direction and leadership to cross-functional teams. The position requires the ability to develop project plans, implement strategy and manage tactical activities while communicating effectively with stakeholders.  The Senior Program Manager is responsible for ensuring project commitments (scope, schedule and budget) are documented, communicated, and achieved.

Responsibilities

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidance documents and ensure effective communication to the project teams and management.
• Develop and implement advanced project management methodologies, processes, tools, and metrics to drive productivity and ensure business success.
• Establish and maintain project communication tools to facilitate cross-functional collaboration and effective project execution.
• Drive project planning and execution across functions including but not limited to Regulatory, Engineering, Clinical, Quality, Manufacturing, Labeling, and Supply Chain teams.
• Direct day to day activities for multiple workstream teams by managing project plans, reporting status updates, and resolving issues, with accountability for deliverables for which multiple functional organizations are responsible.
• Foster close collaboration between team members in various remote/hybrid locations to ensure seamless coordination.
• Facilitate establishing timelines and budgets for projects as chartered.
• Identify hazards and mitigate risk associated with project scope and timelines.
• Develop and communicate key project updates to senior management.
• Monitor documentation maintenance throughout all phases of projects.
• Manage query resolution process using sound project management skills in collaboration with cross-functional technical teams.
• Prepare high quality presentation materials to meet project objectives and for internal and external communication.
• Update departmental procedures and work instructions, as required.
• May lead projects as required and assigned.
• Implement or oversee data management systems for tracking regulatory submissions, project milestones, and compliance metrics. 
• Perform other duties as assigned by supervisor.
• Up to 25% travel is anticipated.

Qualifications

• Experience managing projects with hybrid/remote teams throughout the product development lifecycle.
• Experience with regulatory submissions such as IDEs, PMAs, or EU MDR technical documentation.
• Strong technical skills and knowledge of project management tools.
• Familiarity with the medical device industry, and knowledge of regulations including EU MDR, design control, design transfer, risk management, and change control processes.
• Strong project management skills, with the ability to manage complex timelines and mitigate risks related to regulatory approvals and quality control.
• Excellent communication and interpersonal skills, with the ability to work effectively with diverse teams and stakeholder groups.
• Proficiency with regulatory submission tools and project management software.
• Exceptional problem-solving skills with a proactive approach to identifying risks and creating solutions.

Education:

• A Bachelor's degree in engineering, science, business administration, or a related field.
• Advanced project management